Exploratory, non-randomized, 3-group, microdosing clinical trial to investigate Gallium-68 (68Ga) labeled Platelet-Derived Growth Factor Beta (PDGFRß) targeting Positron Emission Tomography (PET) tracer (68Ga-ATH001) binding in the lungs in healthy participants versus participants with Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
This early-stage medical study is investigating a new type of body scan for the lungs. Researchers are using a special, safe tracer called 68Ga-ATH001, which can be seen by a PET scanner. The aim is to see how this tracer binds in the lungs of people with a condition called Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), and to compare this with healthy individuals. SSc-ILD is a condition where the lungs can become scarred, making it harder to breathe. By understanding how this tracer works, scientists hope to learn more about the disease and potentially find new ways to diagnose or monitor it in the future. This is a very early study and will involve a small number of participants.
At a glance
What is this study about?
This study is a bit like taking a special photograph of your lungs. Scientists are trying out a new method that involves a tiny, safe amount of a special substance called 68Ga-ATH001, which acts like a dye. This dye can be seen with a special scanner called a PET scanner. The idea is to see how this dye attaches to certain parts of the lungs, specifically something called Platelet-Derived Growth Factor Beta (PDGFRß) – you don't need to worry about the confusing name!
We want to see if the dye behaves differently in the lungs of people who have Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) compared to people with healthy lungs. SSc-ILD is a condition where the lungs can become damaged and scarred, making it difficult to breathe. By understanding how this dye works and what it attaches to, researchers hope to learn more about how SSc-ILD affects the lungs.
Ultimately, the goal of this early research is to find new and better ways to understand, diagnose, or even monitor the progress of SSc-ILD in the future. This kind of study helps build the foundation for potential new treatments or diagnostic tools that could benefit patients down the line.
Key takeaways
- This study uses a special scan to look at lung health.
- It compares healthy people with those who have SSc-ILD.
- The goal is to understand SSc-ILD better for future treatments.
- It's an early-stage study, helping build medical knowledge.
- Participation involves a scan and health checks.
Who may be eligible?
This study is open to adults aged 18 and over, both men and women. We are looking for two main groups of people to take part.
One group will be healthy volunteers. These are people who do not have any major medical conditions, particularly lung conditions. They will help us understand what a 'normal' lung scan looks like with our new dye.
The other group will be people who have been diagnosed with Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). This will help us see how the dye behaves in lungs affected by this specific condition. More detailed health checks will be done to make sure it's safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), or are you a healthy volunteer?
- Are you able to attend clinic appointments for scans and check-ups?
- Are you willing to have an injection of a special dye and a PET scan?
- Are you able to understand and agree to the study requirements?
What does participation involve?
As this is an early-stage study, participation will involve a few visits to a clinic. You will undergo assessments to ensure you are suitable for the study, which might include blood tests, health checks, and discussions about your medical history. If you are eligible, you will receive a small, safe dose of the special dye (68Ga-ATH001) as an injection. Afterwards, you will have a PET scan, which is a type of imaging test to see where the dye goes in your lungs. There will also be follow-up checks, likely including more blood tests, to make sure you are well and to see how your body processed the dye. The total duration of your involvement, including all visits and follow-ups, will be explained in detail before you decide to take part.
Potential risks and benefits
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Common questions
What is SSc-ILD?
SSc-ILD is a long-term condition that affects the lungs, where they can become scarred and stiff, making it harder to breathe.
What is a PET scan?
A PET scan is a special type of body scan that uses a small amount of a safe, temporary dye to show how your organs are working inside.
Will the dye make me feel unwell?
The dye is given in a very small, safe amount. Usually, people don't feel anything, or only a brief cold sensation when it's injected.
How long does the study last for me?
The total time you will be involved, including all visits, will be explained in detail by the study team, but it's typically over a short period.
Do I have to do anything special before the scan?
You might be asked not to eat or drink for a few hours before the scan, but the study team will give you clear instructions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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